TPLC - Total Product Life Cycle

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Device	stimulator, peripheral nerve, implanted (pain relief)
Product Code	GZF
Regulation Number	882.5870
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	819	819
Migration	171	171
Use of Device Problem	109	109
Insufficient Information	86	86
Migration or Expulsion of Device	60	60
Appropriate Term/Code Not Available	38	38
Malposition of Device	33	33
Improper or Incorrect Procedure or Method	26	26
Material Erosion	25	25
Device Unsafe to Use in Environment	24	24
Fracture	24	24
Off-Label Use	20	20
Material Protrusion/Extrusion	14	14
Expulsion	13	13
Inappropriate/Inadequate Shock/Stimulation	12	12
Intermittent Communication Failure	10	10
Patient-Device Incompatibility	10	10
Patient Device Interaction Problem	9	9
High impedance	9	9
Battery Problem	7	7
Impedance Problem	7	7
Therapeutic or Diagnostic Output Failure	7	7
Break	6	6
No Apparent Adverse Event	4	4
Detachment of Device or Device Component	4	4
Unintended Electrical Shock	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Temperature Problem	3	3
Device-Device Incompatibility	3	3
Pocket Stimulation	2	2
Overheating of Device	2	2
Fluid/Blood Leak	2	2
Communication or Transmission Problem	2	2
Physical Resistance/Sticking	2	2
Lack of Effect	2	2
Microbial Contamination of Device	2	2
Material Integrity Problem	1	1
Expiration Date Error	1	1
Inadequate or Insufficient Training	1	1
Nonstandard Device	1	1
Device Alarm System	1	1
Biocompatibility	1	1
Failure to Deliver Energy	1	1
Sparking	1	1
Incomplete or Inadequate Connection	1	1
Failure to Conduct	1	1
Device Dislodged or Dislocated	1	1
Activation Problem	1	1
Device Handling Problem	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Inadequate Pain Relief	303	303
Post Operative Wound Infection	184	184
Pain	183	183
Erosion	160	160
No Clinical Signs, Symptoms or Conditions	113	113
Impaired Healing	109	109
Skin Infection	101	101
Skin Inflammation/ Irritation	97	97
Electric Shock	73	73
Unspecified Infection	61	61
Swelling/ Edema	52	52
Discomfort	47	47
Burning Sensation	43	43
Skin Erosion	30	30
Wound Dehiscence	27	27
Insufficient Information	27	27
Purulent Discharge	27	27
Erythema	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Cellulitis	17	17
Fluid Discharge	15	15
Skin Irritation	14	14
Bacterial Infection	14	14
Implant Pain	13	13
Pocket Erosion	12	12
Blister	11	11
Numbness	10	10
Hemorrhage/Bleeding	9	9
Hypersensitivity/Allergic reaction	7	7
Rash	7	7
Failure of Implant	7	7
Drug Resistant Bacterial Infection	6	6
No Code Available	6	6
Tissue Damage	5	5
Fever	5	5
Itching Sensation	5	5
Hematoma	5	5
Shock from Patient Lead(s)	5	5
Stroke/CVA	5	5
Dizziness	4	4
Cardiac Arrest	3	3
Inflammation	3	3
Abscess	3	3
Cramp(s) /Muscle Spasm(s)	2	2
Granuloma	2	2
Post Traumatic Wound Infection	2	2
Skin Discoloration	2	2
Myocardial Infarction	2	2
Respiratory Arrest	2	2
Chills	2	2